HAZARD TESTING & WARNINGS:
Raw materials used in the manufacture of this product have been tested at the donor unit level for HBsAg, Anti-HIV-1/HIV-2, HIV-1 Antigen, and HCV Ab by FDA approved test kits and all results were non-reactive.
CAUTION: NO TEST CAN GUARANTEE A PRODUCT TO BE NON-INFECTIOUS. THEREFORE, ALL MATERIAL DERIVED FROM HUMAN FLUIDS OR TISSUES SHOULD BE CONSIDERED AS POTENTIALLY INFECTIOUS.
Use Statement: For use in Research or Remanufacture of non-injectable products not subject to license under PHS Act Section 351 only.